J Dig Cancer Res.  2023 Aug;11(2):104-107. 10.52927/jdcr.2023.11.2.104.

New Drug Listing Process and Reimbursement Standard Management

• Bai YK
• You MY

• KMID: 2545359
• DOI: http://doi.org/10.52927/jdcr.2023.11.2.104

Abstract

The Ministry of Health and Welfare of Korea has implemented various social security programs to ensure a basic standard of living and raise overall quality of life for all citizens. The Korean social security system provides social insurance, public assistance, and social welfare services.To achieve adequate drug benefits, the Drug Management Department of Health Insurance Review and Assessment Service (HIRA) implement drug management duties including drug listing, upper price limit setting, scope of benefits, and post-factum management. When a manufacturer or an importer wants to apply for National Health Insurance (NHI) coverage of the drug that has obtained safety and efficacy approval, the pharmaceutical benefit assessment committee of HIRA evaluates the drug’s clinical efficacy and cost-effectiveness to determine whether or not to include the drug into the benefit package. The benefit standards for a listed drug (ingredient) are set either for the whole permitted range or a part of range with conditions. To increase the coverage rate for new drugs, the listed drugs are regularly reviewed for their value. The status of listed drugs can be adjusted or eliminated from the benefit package if the clinical efficacy turns out to be insignificant. Therefore, through these pharmaceutical management procedures, high-quality drugs are provided at reasonable prices, which save healthcare expenditure by price determination and selective coverage in consideration of economic evaluation.

Keyword

Pharmaceutical management procedures; Health Insurance Review and Assessment Service (HIRA); National Health Insurance (NHI); Pharmaceutical Benefit Assessment Committee